Regulatory Affairs CMC Dossier Development

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Vaccines & Prevention we are searching for a Regulatory Affairs CMC Dossier Development.

Are you looking for a challenging job in regulatory affairs? Do you have experience with Module 3 dossier development? This can be the right job for you!

In this position you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You will coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. You coordinate the timeline, virtual documents and generation of the Quality module. You will represent the department on multi-functional project development teams to support regulatory filings.
Other responsibilities:
  • Author/drive sections of the CMC dossier and evaluate/ensure that final versions comply with regulatory requirements;
  • Support the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications;
  • Evaluate and ensure the completeness, accuracy, and compliance of data provided for all regulatory submission;
  • Support dossier strategy / product development plan creation at a compound level;
  • Direct responsibility for project budgets;
  • Lead dossier authoring activities for late stage projects for regulatory filings;
  • Identify business improvement areas and drives implementation of improvements;
  • Develop process and business improvements and align with other departments as needed;
  • Interface directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD/PDMS customers such as GCO and TA;
  • Combine technical expertise with management skills;
  • Manage functional or project teams with up to 10 members.

Profile

The ideal candidate has a PhD with PostDoc and at least 3 years of relevant experience. University degree with at least 6 years of relevant experience will also be considered. You have experience with Module 3 Dossier Development for premarketing INDs/IMPDs or MAA/BLA.

Benefits

Project for 7 months. Longer-term anticipated.
Full time preferred, 32 hours discussable. Flexible on location though commitment expected to come to Leiden 1-2 days per week.

Company profile

Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.

Location

Leiden

Company

CLS Services

Publication date

11.03.2019

Publication end date

10.05.2019

Vacature delen via:

Jumpstart your career

Join BioBusiness Summer School to jumpstart your career in Life Sciences by gaining knowledge of business aspects such as product development, IPR, finance and business models. The next edition of the summer school will be organised from 24-28 June 2019 in Amsterdam, the Netherlands.

Why participate

The BioBusiness Summer School is a programme tailored to bridge the gap. By immersing yourself in the business aspects of Life Sciences during this programme, you will learn the basic knowledge of BioBusiness, gain insight in the world of Life Sciences companies, meet leading business leaders and increase your international network.

Employers meet talent

Is your organisation interested in early-career talents in Life Sciences? BioBusiness Summer School can get you in touch with business oriented PhDs, postdocs or Master students. More info can be found here.